On September 26, the general administration of the general administration of communications (sepa) ordered that the company stop selling the whole country!
Released on September 23, the state food administration of drug safety administration of the vibration of shanxi east Anglia, biological pharmaceutical co., LTD. Safflower injection and jiangxi qingfeng-xiangguang fracture pharmaceutical co., LTD. Xi phlogistic flat injection quality problem of circular no. 153 (2017) ".
▍ problem drugs have been sold to many provinces
Vibration, according to the notice of shanxi east Anglia involved lots of biological pharmaceutical co., LTD. Production of safflower injection were sold to shanxi, jiangsu, anhui, fujian, shandong, henan, hunan, guizhou, shaanxi, xinjiang and other 10 provinces (area).
Jiangxi qingfeng-xiangguang fracture pharmaceutical co., LTD. Production involved batch xi phlogistic flat injection were sold to Beijing, tianjin, hebei, shanxi, Inner Mongolia, liaoning, jilin, heilongjiang, jiangsu, zhejiang, anhui, fujian, jiangxi, shandong, henan, hubei, hunan, guangdong, guangxi, hainan, chongqing, sichuan, yunnan, shaanxi, gansu, qinghai, ningxia, xinjiang and other 28 provinces (autonomous regions and municipalities).
Serious adverse reactions have been reported in five provinces (districts) of shandong, xinjiang, gansu, heilongjiang and jiangsu. In addition to stop using and recall the above batch products, national food drug safety administration ordered the two companies to stop the product sales, and in shanxi, jiangxi food and drug administration, under the supervision of an overhaul of drug quality problems, to find out the reason for rectification. Sales will not be resumed until the cause has been identified and the rectification is in place. To investigate the relevant drug production enterprises, and seriously investigate and punish violations according to law.
▍ xi phlogistic flat is widely used in pediatrics
Xi phlogistic flat injection is traditional Chinese medicine injection, composition is paniculta lactone iodo, food and drug administration approved the directions say it "qingrejiedu, cough flow field", used for bronchitis, tonsillitis, bacterial dysentery and other diseases. The drug has been listed for more than 30 years and is widely used clinically.
In 2016, xiyanping injection was ranked in the top three in the market of Chinese traditional Chinese medicine injection, which is the national insurance category, and also the product of multiple provinces and cities. However, it is important to note that in the remarks column of the new health care catalogue, it is clear that it can be used only in patients with severe cases of secondary hospitals.
▍ safflower injection instruction has been revised
The main ingredient of safflower injection is safflower, which can be treated as activating blood stasis to treat occlusive cerebrovascular disease, coronary heart disease, angiitis.
Safflower injection is the national health insurance category, and the contents of the health care catalogue clearly show that the patients with the second level of the drug have the ability to rescue clinical evidence.
On August 27, 2012, the CFDA the illustrations of the safflower injection was revised, the requirements in the specification of safflower injection increase warnings "the adverse reactions, including allergic shock, should be used in rescue conditions of medical institutions, drug after allergic reactions or other serious adverse reactions should be stopped immediately and timely treatment".
▍ frequent adverse reactions
Although Chinese medicine injection in clinic has played a very important role, but in recent years TCM injections have appeared much death incidents make it into the "exit", especially since "heartleaf houttuynia herb injection" events, people, etc on the safety of TCM injections.
Experts say the primary reason for the adverse reaction of traditional Chinese medicine injection is unstable raw materials. Due to the differences in the origin of medicinal materials, the contents of soil, climate, harvest season and other planting conditions may have different contents, and the same medicinal materials of different base sources are more different. The instability of the quality of medicinal materials often results in the difference of quality between batches of traditional Chinese medicine injection, which can lead to different adverse reactions.
Many of the components of traditional Chinese medicine injection injected into the body can be potential allergens, including component in the process of preparation and placement is also likely to further create new impurities and insoluble particles, coupled with the production process and quality control of a variety of shortage, all these factors make the Chinese medicine injection adverse reaction problems mount.
▍ market is greatly limited
Traditional Chinese medicine injections have long been controversial, and their safety is widely criticized as a product of the modernization of traditional Chinese medicine. In this case, TCM injections still sell hundreds of millions of brands in many markets.
As security issues have become more prominent, the country has begun to limit the use of traditional Chinese medicine injections from medicare and assisted drugs.
Some sanjia hospitals are already reducing the use of traditional Chinese medicine injections. In addition, jiangsu, anhui, yunnan and Beijing have issued auxiliary medicine directories, which explicitly restrict the use of adjuvants and require medical institutions to pay attention to the use of them.
Previously, medical insurance, director of the institute of southeast university Zhang Xiao said, the latest edition of the medical insurance directory 26 most be restrictions on the use of TCM injections for adjuvant drugs, after the medical insurance directory periodically adjusted, more and more auxiliary medication in TCM injections will be withdrawn from the medical insurance directory.
On February 27, the director of the state administration of food and drug administration, bi jingquan, offered to launch the safety and effectiveness of TCM injections. He also publicly emphasized the work at the launch of the national safe medicine month in October.
Some people in the industry said that Chinese medicine injection could carry out the evaluation of the efficacy and safety of similar generic drugs in the future. This means that companies that produce the same products will be eliminated in the future, and many companies with less good results and a single homogenous product will likely be eliminated.
Do generics of generics in the same kind of consistency evaluation big shuffle, will it be repeated in the traditional Chinese medicine injection?
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